Onconostic Technologies -3N Diagnostics Group (OT/3NDx), is an oncology company that already has an immunohistochemistry (IHC) tumor biopsy assay to guide personalized treatment selection for hormonal therapy, chemotherapy, and immunotherapy for breast cancer patients. Pulse 2.0 interviewed OT/3NDx founder and Chairman Dr. Partha Ray, MD, to learn more about the company.
Dr. Ray’s Background
What is Dr. Ray’s background? Dr. Ray said:
“I am a Surgical Oncologist by training, having graduated from MCP Hanneman College of Medicine, Drexel University, Philadelphia PA. I pursued my residency in General Surgery from Robert Wood Johnson University Hospital in New Brunswick, NJ, and then pursued surgical oncology fellowship training at the John Wayne Cancer Institute (JWCI) in Santa Monica CA. I entered the oncology field to help save cancer patients’ lives. Following my fellowship training I began my academic career and practice in oncology in Urbana, Illinois in 2010.”
“I soon realized that with the treatments currently available to us, we were essentially powerless to positively impact a patient’s outcome if they had an aggressive variety of cancer unless it was identified early enough. The problem was that there was no way to tell aggressive cancer apart from non-aggressive cancers: they both had identical features when viewed under a microscope. I knew that the early detection of aggressive cancers, and the heightened metastatic risk that they represented was the key to success in achieving improved outcomes for our patients because then we could intervene with more aggressive treatment options early in the disease process.”
Formation Of OT/3NDx
How did the idea for OT/3NDx come together? Dr. Ray shared:
“The concept for VERESCA FOXC1 started in 2008 when I was a surgical oncology fellow at JWCI. For my research project, I wanted to find a simple technique that would help distinguish aggressive subtypes of cancer from non-aggressive subtypes at the molecular level. To seek an answer to this fundamental but very important question, I foraged through publicly available data sets with bioinformatics software and discovered a gene, Forkhead Box C1 (FOXC1), which evidently imparted aggressive traits to the most aggressive subset of breast and many other types of cancer.”
“Finding FOXC1 was equivalent to finding a needle in a haystack from a pool of more than 30,000 genes. That this one biomarker can stratify patients into aggressive and non-aggressive subtypes is truly remarkable when compared to the ever-increasing numbers of expensive combination molecular panels. After the discovery of the FOXC1 gene and experiments that proved that it was mechanistically linked to imparting aggressive traits to breast cancer cells and not merely associated with it as a ‘bystander effect,’ it occurred to me that we could very well extrapolate this discovery to developing a ‘Diagnostic Test’ that could segregate patients who had an aggressive subset of cancer from those, whose cancer was non-aggressive and treatable. With these initial thoughts, we formed the company OT/3NDx.”
Favorite Memory
What has been Dr. Ray’s favorite memory of working for the company so far?
“The realization and understanding that the FOXC1 biomarker not only discriminates aggressive cancer from non-aggressive cancer but is a pan-cancer, tissue-agnostic marker of cell plasticity (one which imparts flexibility, metastatic capability, drug resistance, and immune evasiveness to cancer cells) and has universal application in predicting therapeutic efficacy (or lack thereof) irrespective of the class of drug administered or the type of cancer treated. This was truly the ‘Aha moment’ for us. We knew that we had a viable solution to impact the outcomes of hundreds of thousands of cancer patients.”
Core Products
What are the company’s core products and features? Dr. Ray explained:
“VERESCA FOXC1 has been specifically designed to be a simple test that can be sent out to a pathologist anywhere in the world. It fits into already established workflow on existing equipment without the need for any new platform or special training. If a lab can run immunohistochemistry (IHC) tests, they can run our VERESCA test and it’s the first and only test that detects and grades tumor aggressiveness via proprietary predictive algorithms that help to clearly predict the efficacy of chemotherapy and/or immunotherapy and help design tailored therapy specific to a patient. In summary, the VERESCA FOXC1 IHC test is the torch bearer for next-generation Precision Oncology.”
Challenges Faced
What challenges have Dr. Ray and the team faced in building the company? Dr. Ray acknowledged:
“Frankly, it was a daunting challenge to start the company from scratch. There were so many questions: how broadly applicable will this test be and how best to implement and market the FOXC1 test? There were IP questions, regulatory questions, and go-to-market questions. Then, of course, there is the big barrier of funding and the best advice seemed to be don’t try to do all this myself.”
“That’s when I decided to find an expert team of people with diagnostic company experience, where they had done all these things in prior companies. Perhaps this was the best decision I could have made to set the company on a proper track from the outset.”
“I was lucky to find an awesome team of people, who came as a sort of ‘package deal’ because they all had worked together at a variety of San Diego diagnostic and biotech companies, most of which they had founded and were executives from concept to exit. This was ‘just another rodeo’ for them.”
“Aside from expertly answering all these questions together, their practical know-how saved missteps along the way and accelerated development and regulatory approval greatly. In addition, I was able to find ways to exploit and leverage existing human cancer gene expression datasets and clinical trial data sets to conduct ‘retrospective’ studies of FOXC1 in various disease scenarios to best identify clinical trials to become part of, where we could forecast with high probability in advance, what study outcomes are likely to be. This has saved us many tens of millions of dollars and will continue to do so.”
Evolution Of OT/3NDx
How has the company’s technology evolved since launching? Dr. Ray noted:
“After the Diagnostic Test, we developed the prognostic algorithms that could help us predict the overall survival of patients with FOXC1 positive cancer. Gradually, we came forward with predictive algorithms that could predict the efficacy of drugs (mainly chemotherapeutic drugs) in FOXC1 positive cancer. Next, we came up with algorithms that could predict the therapeutic efficacy of Immune Checkpoint Inhibitors’ and other targeted therapies in cancer. Thus, the VERESCA FOXC1 test has evolved to become a theranostic biomarker which would help guide precision oncology decisions for various treatment modalities.”
Significant Milestones
What have been some of the company’s most significant milestones? Dr. Ray cited:
“The VERESCA FOXC1 test has successfully helped segregate patients with basal-like breast cancer from non-basal like breast cancer within the triple-negative breast cancer cohort in a Phase 3 clinical trial setting and correctly predicted that the non-basal group derives very robust and clear survival benefit with extended adjuvant capecitabine therapy. We presented this data at the 2024 ASCO Annual Meeting.”
Customer Success Stories
After asking Dr. Ray about customer success stories, he highlighted:
“The CIBOMA trial is a success story in breast cancer. Here the study was failing to identify patients for whom Capecitabine is beneficial. The VERESCA test was then used to successfully stratify aggressive and non-aggressive subtypes, and the aggressive subtype outcomes were significantly better in the predicted responder (non-basal like) patients than the existing standard of care.”
“The Checkpoint 025 trial is another example of a customer success story, this time when prescribing checkpoint inhibitors based upon the PDL-1 test criteria. This prospective Phase III clinical trial established the value of a checkpoint inhibitor drug in advanced/metastatic renal cell carcinoma (amRCC). However, there was no way to predict which patients would derive benefit and which patients would not. A retrospective analysis of trial data utilizing the VERESCA approach successfully predicted that a subset of patients who were being prescribed these drugs would do poorly because they have the aggressive disease subtype. Based on VERESCA test results, patients who met the criteria for prescribing checkpoint inhibitors could now be stratified into aggressive and non-aggressive subtypes. As predicted, patients with the aggressive subtype showed no drug benefit and even shorter survival time when given these drugs. Patients with non-aggressive subtype were clearly segmented from the population and did better on the drugs. This demonstrated checkpoint inhibitor drugs should not be prescribed for the patients with aggressive subtype, which is estimated to be 20% to 25% of patients being prescribed based on PDL-1 expression status alone.”
Funding
When asking Dr. Ray about the company’s revenue and funding, he revealed:
“The company has a CE Mark with a breast cancer use case, allowing sales in 87 countries and in CLIA labs in the USA. We are establishing sales channels in EU countries and expect to book revenues this year. We are also working to establish a sales channel into US CLIA labs, and we are speaking with participants in this market as well.”
“Funding to date has been from founders, friends, and angel investors. Because we have the CE Mark and two clinically validated use cases, we will raise a series A this summer after the ASCO results are made public. We will be looking for value-added investors in precision oncology tests and oncology drug discovery.”
Total Addressable Market
What total addressable market (TAM) size is the company pursuing? Dr. Ray assessed:
“Clinical trial results to date validate the retrospective studies we’ve conducted as a methodology to rapidly expand the use of the VERESCA test to all solid tumors and for monitoring residual metastatic disease in cancer patients in remission. If this is proved accurate, the market for the VERESCA test may be several billion dollars. The current established market for the PDL-1 test alone is around $1B, even though that test is limited to certain cancer types.”
Differentiation From The Competition
What differentiates the company from its competition? Dr. Ray affirmed:
“Only the VERESCA FOXC1 test stratifies aggressive from non-aggressive cancers when the patient’s tumor is diagnosed. Clinical trial results demonstrate the value of this new information at the time of diagnosis when treatment decisions are being made. It may be implemented in any pathology lab like the HER2 test has been. It is low-cost on a relative basis, improves outcomes, and saves money. The test has been meticulously developed to be repeatable and accurate for any pathologist, anywhere. No need to send samples to us.”
Future Company Goals
What are some of the company’s future goals? Dr. Ray concluded:
“To make the test available to as many patients as possible as fast as possible. To this end we seek to actively work and partner with companies that already have global marketing and distribution channels in place. We will also actively partner with biopharma to participate in the development of new drugs that target plasticity because 90% of cancer patients die because of plasticity. Such drugs are likely to also have a much lower side effect profile as targeting FOXC1+ cells will by definition not target normal non-cancer cells.”
